The implementation of a quality system is a requirement for any manufacturer of medical devices in the US, regardless of its classification, i.e. whether it needs a 510(k) filing or not. The specific requirements for these systems are defined by the FDA in the form of the QSR (Quality System Ruling). These rules are similar to what is used by the ISO quality system standard, however, with some additional processes and procedures, mainly in the area of complaint handling.
OTech has assisted with the implementation of the QSR quality systems. This implementation is highly customized and depends on what the vendor has in place. It can consist of either a review, for example:
Advanced PACS, DICOM, HL7 Troubleshooting
Fundamentals of Clinical and IT (PARCA CPAS)
PACS System Administration
Comprehensive HL7 (V2)
CDA IN A DAY (HL7 V3)
Certified EMR Administrator Training
Click here to view entire training schedule.
Click here to view the latest video regarding the DICOM sniffer.